BREAKTHROUGHS BLOG

September 18, 2013

New GHTC resources highlight FDA’s critical role in global health

The GHTC has long stressed that the US Food and Drug Administration (FDA) plays a critical part in efforts to improve global public health. While the FDA
is best known for its work to protect the health of US consumers, the agency has a strong history of sharing its expertise to benefit people worldwide
and is playing an increasingly vital role in global health issues. The GHTC has released two new resources that provide fresh evidence on the FDA’s
growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and
save lives worldwide.

Our new fact sheet and
policy brief focus on five key areas at the FDA. First, the FDA leads numerous international
programs from its headquarters in the United States and operates offices and posts in ten countries across the globe. As the agency expands and deepens
its contributions to global health, it is essential to ensure FDA’s activities contribute to an agency-wide strategy. Therefore, the FDA should create an office of neglected diseases so that it can better drive coordination among its centers and offices to maximize its global—and domestic—health impacts. This new program
should be housed within the FDA’s Office of the Commissioner. By formalizing the agency’s global health activities, better oversight can help ensure
that related programs and initiatives contribute to a unified goal.

The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations
for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Credit: PATH

Second, the FDA should continue to build partnerships with global regulatory stakeholders, such as the World Health Organization and national
regulatory authorities. Regulatory review of products designed for use in the developing world can be particularly challenging, especially when the
national regulatory authorities do not have the capacity or resources to manage the reviews. To address this issue, the FDA offers trainings and contributes
to global efforts to improve regulatory harmonization. The agency also supports a variety of global regulatory initiatives. But this is just the beginning.
To realize the positive impacts of these investments, FDA should continue to contribute to and expand these efforts.

Third, while FDA has taken impressive steps to increase its engagement globally, without formalized reporting and oversight mechanisms the outcomes of
this work can wane in the face of other priorities and funding constraints. To increase transparency and accountability for its global health commitments,
the FDA should take steps to establish formalized processes to report to Congress on its neglected disease activities.

Fourth, while its first priority is the health of Americans, it is essential that the FDA arms itself with global health experts who can help carry out
a comprehensive plan. To strengthen the work already being conducted in the agency’s international offices and posts, FDA should dedicate additional staff members and resources to global health engagement.

Finally, FDA—like so many agencies across the US government—is facing severe financial constrains due to sequestration and broader budget cuts.
We’re facing the possibility of a government shutdown at the end of this month, as congressional policymakers still have not reached an agreement on the federal budget. Without question, this financial
uncertainty hinders FDA’s ability to strengthen its role in global health and safeguard the health of American citizens. It’s critical that congressional policymakers pass a smart budget agreement that avoids another round of sequestration cuts while protecting key programs at FDA and other federal agencies that work in global health.
As House and Senate leaders continue their budget negotiations, they have the opportunity to demonstrate their commitment to lifesaving and efficient
programs at leading agencies like the FDA.